Components and methods for a catheter positioning system with a spreader and track

ABSTRACT

Embodiments include a resealable delivery channel in a catheter positioning system configured to receive a catheter introduced by a spreader. The spreader may have shapes configured to help users insert the spreader and a catheter into the resealable delivery channel and to retain the spreader and the catheter within the resealable delivery channel The resealable delivery channel may be shaped to accommodate the spreader or catheter. The resealable delivery channel may include flexible plastic lips that are moveable to facilitate insertion of the spreader and a catheter into the resealable delivery channel

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. Non-Provisional ApplicationSer. No. 14/494,693, entitled COMPONENTS AND METHODS FOR A CATHETERPOSITIONING SYSTEM WITH A SPREADER AND TRACK, filed on Sep. 24, 2014,which claims the benefit of priority to U.S. Provisional PatentApplication No. 61/883,298, entitled “COMPONENTS AND METHODS FOR ACATHETER POSITIONING SYSTEM WITH A SPREADER AND TRACK,” filed Sep. 27,2013, the entire contents of both which are hereby incorporated byreference for all purposes.

BACKGROUND

Many invasive medical procedures require the use of radiation tovisualize and track the location of an inserted device. For example,procedures involving catheter insertion, such as invasiveelectrophysiology procedures, rely on fluoroscopy or other radioactiveimaging techniques to help navigate and position the catheter within apatient's body at a particular site, such as in the heart or inside ablood vessel in the circulatory system.

High dosages of radiation may have long term adverse health effects. Apatient may be directly exposed only once or twice to radiation duringsuch procedures and avoid such adverse effects. However, physicians,medical technicians and staff can experience a large cumulativeradiation dosage over time, both directly and indirectly, fromconducting many procedures.

To protect the operator and staff from this radiation, shielding such aslead aprons, gowns, glasses, skirts, etc., is worn. Such lead clothing,especially a lead apron, is quite heavy and uncomfortable, and its usehas been associated with cervical and lumbar spine injury ordegradation.

SUMMARY OF THE INVENTION

Various embodiments include a catheter positioning system having aresealable delivery channel configured to guide a catheter as thecatheter positioning system advances or retracts the catheter withrespect to a patient. The catheter may be inserted into the resealabledelivery channel, such as through a resealing groove with flexibleplastic lips running along the top of the delivery channel A spreadermay spread the flexible plastic lips and guide the catheter into theresealable delivery channel In various embodiments, part or all of thespreader may move with the catheter during positioning, such as rotatingwith the catheter. The various embodiments include spreaders of variousshapes configured to help users insert the catheter into and remove thecatheter from the flexible plastic lips of the resealable deliverychannel In one embodiment the spreader includes flange shaped tip, andin another embodiment, the spreader includes a bulb shaped tip.

In further embodiments, the resealable delivery channel may be shaped toaccommodate the spreader or catheter. For example, the flexible plasticlips may be deflected in certain directions. In alternate embodiments,the flexible plastic lips may be adjustable such that a user can movethem in various directions.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated herein and constitutepart of this specification, illustrate exemplary embodiments of theinvention, and together with the general description given above and thedetailed description given below, serve to explain the features of theinvention.

FIG. 1 is a top view of a catheter suitable for use in the variousembodiments.

FIG. 2 is an oblique view of a remotely controlled catheter positioningdevice in suitable for use with the various embodiments.

FIG. 3 is an exploded view of a catheter handle portion, a modularplate, and a sled member suitable for use with the various embodiments.

FIG. 4 is an oblique view of a catheter handle portion, a modular plate,and a sled member coupled together suitable for use with the variousembodiments.

FIG. 5 is a top and side view of a remote controller suitable for usewith the various embodiments.

FIG. 6 is a system block diagram illustrating a remote controller, aremotely controlled catheter system, and a programmable control systemsuitable for use with the various embodiments.

FIG. 7A and FIG. 7B are profile views of an embodiment sterile barrierand resealable delivery channel suitable for use in a catheterpositioning system.

FIG. 7C is a perspective view of an embodiment sterile barrier andresealable delivery channel of FIG. 7A and FIG. 7B suitable for use in acatheter positioning system.

FIG. 8 is a profile view of an embodiment resealable delivery channelwith inward slanted flexible lips.

FIG. 9A and FIG. 9B are profile views of an embodiment resealabledelivery channel with hinged flexible lips.

FIG. 10 is a profile view of a spreader with a tip guiding a catheterinto a resealable delivery channel according to an embodiment.

FIG. 11 is a top view of an embodiment spreader with a flanged tip.

FIG. 12A is a profile view of an embodiment resealable delivery channelshaped to fit a spreader with a flanged tip.

FIG. 12B is a profile view of another embodiment resealable deliverychannel shaped to fit a spreader with a flanged tip.

FIG. 13 is a side view of an embodiment spreader with a bulb tip.

FIG. 14 is a profile view of an embodiment resealable delivery channelwith a spreader with a bulb tip.

FIG. 15 is a top view of an embodiment resealable delivery channel in asled base.

DETAILED DESCRIPTION

Various embodiments will be described in detail with reference to theaccompanying drawings. Wherever possible, the same reference numberswill be used throughout the drawings to refer to the same or like parts.References made to particular examples and implementations are forillustrative purposes and are not intended to limit the scope of theinvention or the claims.

Various embodiments provide improved components for introducing acatheter into a resealable delivery channel within a catheterpositioning system. The catheter positioning system enable a physicianto remotely control manipulation and insertion of a catheter into apatient while being positioned away from sources of radiation used forimaging or other procedures. The catheter positioning system may be usedto move an attached catheter, such as advancing or retracting thecatheter in relation to a patient or within a patient's body in responseto control inputs on a remote controller. The catheter positioningdevice may also be used to actuate the catheter, such as by controllingan actuator on a catheter's handle. Catheter actuators may performvarious tasks, such as deflecting a tip to help in navigation orcontrolling one or more transducers to assist in an operation.

In various embodiments, the catheter positioning system includes aresealable delivery channel configured to guide the catheter as thecatheter positioning system advances or retracts the catheter. Theresealable delivery channel helps to prevent the catheter from bucklingas it is advanced into the patient. The resealable delivery channel mayfurther help to maintain a sterility boundary between the operatingmechanisms of the catheter positioning system and the operative parts ofthe catheter, which may come into contact with the patient. The cathetermay be inserted into the resealable delivery channel through a resealinggroove with flexible plastic lips running along the top of the deliverychannel A spreader is used to spread the flexible plastic lips and guidethe catheter into the resealable delivery channel The flexible plasticlips may include one or more entry holes to enable the spreader to slideinto the resealable delivery channel Part or all of the spreader maymove with the catheter during positioning, such as rotating with thecatheter. The resealable delivery may be hinged to open the resealabledelivery channel to receive the spreader and close the resealabledelivery channel around the catheter. In some embodiments, theresealable delivery channel may provide a seal around the catheterwithin the delivery channel In other embodiments, the resealabledelivery channel may close around the catheter without necessarilyproviding a seal, in which case the lips may close enough to prevent thecatheter from buckling and riding out of the delivery channel

The various embodiments provide improved designs for spreader includingshapes for the spreader tip that ease insertion and removal of thespreader through the flexible plastic lips of the resealable deliverychannel For example, the spreader may have flanges or a bulb shaped tip.

In further embodiments, the resealable delivery channel may be shaped toaccommodate the spreader or catheter. For example, the flexible plasticlips may be deflected in certain direction. In alternate embodiments,the flexible plastic lips may be adjustable such that a user can movethem in various directions.

FIG. 1 illustrates an example catheter 100 that may be used with variousembodiments. The catheter 100 may include a handle portion 102, a tubeportion 116 and a tip portion 118. The handle portion 102 may be locatedat a proximal end of the catheter 100 while the distal end of the tubeportion 116 may be inserted into the body of a patient.

The handle portion 102 of the catheter 100 may also include anirrigation port 110, which may be used to introduce water or otherfluids to irrigate an operating site of the catheter tip, to lubricatethe catheter and ease insertion or retraction in the patient, and so on.The handle portion 102 may also include a back port 120 through whichone or more wires or cables 112 may leave the handle portion 102. Cables112 may supply power to the catheter 100 and/or may provide a connectionfor transmitting (and/or receiving) signals, such as sending (and/orreceiving) commands from a remote controller or other control device tothe catheter, relaying data from one or more transducers present on thecatheter, and so on.

The handle portion 102 may include actuators to control the behavior ofthe catheter 100. For example, the handle portion 102 shown in FIG. 1includes a front flange 104 a and rear flange 104 b that may be squeezedtogether or pulled apart such that the inner cylinder 108 slides backand forth inside the outer cylinder 106. The sliding motion of the innercylinder 108 may be transferred along the tube portion 116 to move thetip 118 and/or may actuate one or more mechanisms at the tip 118 of thecatheter.

In various embodiments, a variety of different types of catheters may beused with different actuators or functions, such as actuators fordeflecting the tip of the catheter to ease navigation inside a patientor for controlling one or more transducers at the tip (e.g., electricalleads, one or more sensor devices, ultrasound devices, etc.).

FIG. 2 illustrates an embodiment catheter positioning device 200 with aremote controller 224. The catheter positioning device 200 may include asled base 202 coupled with a sled member 204. The sled base 202 may beconfigured to advance the sled member 204 along the sled base 202towards the body of the patient or back away from the patient. Forexample, the sled member may be moved with a motor 208 at one end of thesled base 202. The sled member 204 may move along a rail or other track,such as a worm drive, back and forth along the longitudinal axis of thesled base 202.

The sled base may be mounted with an arm 212 having articulating jointsto move the sled base 202 and attached components into variouspositions, such as over a working surface or an operating table 220. Thearm 212 may be extended or rotated to position the sled base 202relative to a patient on the operating table 220. The sled base 202 mayinclude a handle 210 to move the sled base 202 into position. The sledbase may also include a nose cone 216 that may be inserted into apatient. Alternately, the nose cone 216 may connect with an introduceror sheath that may be inserted into the patient. A catheter may beadvanced along the sled base 202 and then through the nose cone 216 intothe patient.

The sled base 202 may include a sterile barrier in the form of aresealable delivery channel 218 a to protect and guide the catheteralong the sled base as it is advanced by the sled member 204. Forexample, the catheter may be inserted into the delivery channel 218 aand then the catheter handle 102 may be connected to the sled member 204(such as by using the modular plate 206 discussed below) such that thecatheter is driven forward by translation of the sled member 204 alongthe resealable delivery channel 218 a in the sled base 202 and throughthe nose cone 216 into the patient.

The resealable delivery channel 218 a may be flexible to allow thecatheter to be inserted and removed repeatedly. For example, theresealable delivery channel may have a resealing groove 218 b withflexible plastic lips running along the top of the delivery channelalong the longitudinal axis of the sled base 202. The catheter may bepushed through the resealing groove 218 b to position it inside theresealable delivery channel 218 a where it may be held in place by thespreader 402 (see FIG. 4). As described in more detail below, theplastic lips may separate to let the catheter pass then come backtogether to seal behind the catheter. The catheter may be removed bypulling the catheter back through the flexible plastic lips of theresealing groove. In some embodiments the plastic lips may not form acomplete seal, but rather may separate and close around the cathetersufficient to prevent buckling of the catheter but without forming aseal.

The sled member 204 may be coupled with a modular plate 206 to which acatheter handle 102 may be attached. Various embodiments may includemany alternate modular plates 206 that provide a consistent interfacewith the sled member 204, while providing different catheter interfaces.Modular plates 206 that may accommodate different catheter types whilemating with the sled member 204 may be swapped out so that the catheterpositioning system may be used with many different types of catheters.Depending on the kind of catheter that is desired for a procedure, anappropriate catheter-specific modular plate 206 may be selected andattached through the common interface to the sled member 204. Thespecific type of catheter may be attached to the catheter-specificmodular plate 206. The modular plate 206 may also providecatheter-specific actuator interfaces to integrate with any actuators onthe catheter handle 102, while providing a common actuator interface forengaging actuator controls of the catheter positioning system, therebyallowing an operator to control the actuators via the remote controller224.

The sled member 204 may rotate, thereby rotating a catheter connected tothe modular plate 206. The sled member 204 may also move linearly alongthe sled base 202, thereby inserting or extracting a catheter connectedto the modular plate. The rotational and translational or linearmovement of the sled member 204 may be controlled remotely via theremote controller 224. By controlling translation along the sled base202, rotation of the sled member 204, and actuation of the catheter'shandle via the modular plate 206, an operator may position or use thecatheter in any way necessary for a desired operation. Further, anoperator may control each of these degrees of freedom (i.e.,translation, rotation, and actuation) remotely with the remotecontroller 224.

FIG. 3 illustrates an exploded view of a catheter handle 102, modularplate 206, and sled member 204. The catheter handle 102 may include oneor more actuators 302 to actuate movement of the catheter, such asextension or retraction of the catheter. In some embodiments, thecatheter handle 102 may be provided with a rotatable lever 103 tomanually control movement of the catheter. In some embodiments, movementof the rotatable lever 103 may be activated by the actuators 302. Inother embodiments, the actuators 302 may control additional oralternative movements of the catheter. As discussed above, the modularplate 206 may be swapped in and out so that various catheters withdifferent actuators may be connected to the catheter positioning device.FIG. 3 illustrates a modular plate 206 that includes clamps 304 tosecure the catheter handle 102 as well as a molded nest 306 a configuredto integrate with the actuator 302 such that the rotatable lever 103 maybe controlled by rotating the molded nest 306.

The modular plate 206 may be rigidly, or semi-rigidly connected to thesled member 204 such that translation or rotation of the sled member istransferred through the modular plate 204 to the catheter handle 102 todrive and position the catheter. The sled member 204 and modular plate206 may be connected by one or more detachable joints, such as a socket308 b that may receive a tab 308 a of the modular plate 204. The sledmember 204 may also include a control mechanism 310 to integrate withthe modular plate 206. The control mechanism 310 may allow the operatorto control the catheter's actuators 302. For example, the controlmechanism 310 may be a cam or projection that may fit in a correspondingsocket 306 b of the molded nest 306 a. The operator may thereby controlthe actuators 302, such as by controlling (e.g., rotating) the moldednest 306 a through rotation of the control mechanism 310 in the socket306 b. The socket 306 b and the control mechanism 310 may be of a commonor universal mechanical configuration regardless of the catheterconfiguration for the modular plate 206. Thus, control mechanism 310 mayintegrate with any of the various modular plates 206, which may bedifferently configured to connect with different catheter handles.

FIG. 4 illustrates a catheter or catheter-related component, such as thetube portion 116 connected with the modular plate 206 and sled member204. The spreader 402 may be used to insert the catheter orcatheter-related component such as the tube 116 into the resealabledelivery channel 218 a. As shown in FIG. 4, the spreader 402 may beattached to the modular plate 206 and may be configured to lead thecatheter's tube portion 116 into the resealable delivery channel 218 a.As the sled member 204 is advanced, the tip 408 of the spreader 402 mayremain inside the resealable delivery channel 218. The tip 408 may movethe plastic lips 218 c of the resealable delivery channel 218 a aside sothat the catheter tube 116 does not actually come into contact with theplastic lips 218 c. Thus, the spreader 402 performs the task ofspreading the lips 218 c of the resealable delivery channel 218 a at thepoint of the insertion of the catheter 116. As the sled member 204advances down or retreats up the sled base 202, the spreader 402 and,thus, the point of the insertion of the catheter 116 into the channel,advances or retreats. The plastic lips 218 c may be urged or spread openby the spreader 402, such as to accommodate the spreader 402 in theadvancing or retreating direction and may close behind the spreader 402as it moves. Thus, the spreader 402 ensures that forces from plasticlips are not applied to the flexible catheter, ensuring that rotationalmovement of the catheter is not impeded. In other words, pressure fromthe plastic lips 218 c that may ordinarily pinch against the catheter ortube portion 116 are avoided through the use of the spreader 402.

The spreader 402 may include an attachment portion 404 configured toattach the spreader to the sled member 204 or the modular plate 206. Atthe other end, the spreader 402 may include a tubular extension or mainportion 406 that separates the lips 218 c of the resealable deliverychannel 218 a as the sled member advances and retreats, and a tipportion 408, which is illustrated as hidden within the groove 218 b ofthe resealable delivery channel 218 a. The tip portion 408 may remainwithin the resealable delivery channel 218 a. The catheter may emergefrom the tip portion 408, such as from inside the groove 218 b of thedelivery channel 218 a.

FIG. 5 illustrates an example remote controller 224 from a side and topperspective. The remote controller 224 may include buttons 502 forgenerating signals for controlling the “in” and “out” (e.g., extensionand retraction, forward and backward, etc.) motion of a catheterprovided by sliding the sled member 204 up or down the sled base 202.The remote controller 224 may include a dial 508 at one end forcontrolling rotation of the catheter by generating signals for rotatingthe sled member 204. The remote controller 224 may also include arotatable knob 504 and movable knobs 505 that may send control signalsto the sled member to control actuation of one or more actuators, suchas actuators 302, the rotatable lever 103, and possibly other controlsthat may be on the catheter handle 102. The remote controller 224 mayalso include a rotatable sleeve 506 that may be rotated to provide anadditional user input, such as a user-designated input, or an input forone or more additional controls that may be available on the catheter.The remote controller may also include a push pull user input device 512that may similarly be configured to generate signals to controlactuation of another catheter element. In embodiments, the controlsignals generated by operation of the user inputs may be sent from theremote controller 224 to the catheter positioning device via a wire 520(or wires). Alternatively or additionally, the control signals may besent wirelessly via a transmitter or transceiver module (not shown).

FIG. 6 illustrates a programmable control system 602 as a part of thecatheter positioning system. A remote controller 224 may be connected tothe programmable control system 602 by a wired connection 606 a or awireless connection 606 b such as a wireless data link. The programmablecontrol system 602 may be connected to the catheter positioning device200 by a wired connection 604 a or a wireless connection 604 b such as awireless data link. The connections between the programmable controlsystem 602 and the remote controller 224 and/or the catheter positioningsystem 200 may be any of a variety of available communication interfacesand/or protocols. Alternatively or additionally, the communications maybe at least partially proprietary. In some embodiments, thecommunications may be secure or at least partially secure to protectpatient privacy.

As discussed above, the sled base 202 may be fitted with a sterilebarrier including a resealable delivery channel 218 configured toreceive and guide the catheter along the sled base as it is advanced bythe sled member 204. FIG. 7A and FIG. 7B illustrate a profile of thesterile barrier 702 with the resealable delivery channel 218 a. Thesterile barrier 702 may have one or more supports 706 to secure into thesled base 202. The resealable delivery channel 218 a may include twoflexible plastic lips 712 (e.g., 218 c) that extend along the length ofthe resealable delivery channel 218 a to form a resealable enclosurearound the groove 218 b of the resealable delivery channel 218 a. Asdescribed above, the tube portion 116 of the catheter is guided betweenthe flexible plastic lips 712 by a spreader 402 and into the groove 218b of the resealable delivery channel 218 a. The catheter may extend inthe groove 218 b along the length of the sled base 202 and into a nosecone 216 (as shown in FIG. 2), introducer, sheath or othercatheter-holding component and into the patient.

As illustrated in FIG. 7C, the flexible plastic lips 712 may separate tolet the main portion 406, and the tip of the spreader 402 pass whileholding the body of the main portion 406 within the channel The lips 712may come back together to seal or close behind the main portion 406 ofthe spreader 402 guiding the catheter. In some embodiments, the lips 712may open in front of and close behind the spreader 402 sufficient tohold the catheter within the channel without forming a seal. As thecatheter is positioned, the end of the spreader 402 may stay inside theresealable delivery channel 218 a by moving between the flexible lips712. In other words, the flexible lips 712 may be sealed along thelength of the resealable delivery channel 218 except around the spreader402. The flexible lips 712 may open and close around the spreader 402 asthe catheter is advanced and/or retracted.

FIG. 8 illustrates a profile of an embodiment resealable deliverychannel 218 with a catheter tube portion 116 inside. In an embodiment,the resealable delivery channel 218 may have flexible lips 802 a, 802 bthat slant inward with respect to the resealable delivery channel 218.Flexible lips 802 a and 802 b having an inward slant may allow cathetersor spreaders to more easily be pushed into the resealable deliverychannel 218. The shape and configuration of the flexible lips 802 a and802 b may also help keep catheters inside the resealable deliverychannel as the inwardly-oriented lips 802 a, 802 b can apply aninward-directed spring force on the catheter 116 to reduce theopportunity for portions of the catheter to pop out of the channel.

FIG. 9A and FIG. 9B illustrate another embodiment of a resealabledelivery channel 218 with flexible lips 902 that may be coupled to thedelivery channel 218 by a joint or hinge 904. A lip 902 may be coupledon each side of the channel with a respective joint or hinge 904. In theillustrated embodiment, the full length of the flexible lips 902 maypivot about the joint/hinge 904 to enable easy insertion or removal ofthe catheter. For example, in the illustrated embodiment, the lips 902may be moved (i.e., opened and closed) along the entire length, ratherthan flexing locally, such as where a spreader is inserted. FIG. 9Aillustrates the lips 902 in an upward rotated configuration (e.g., in anopen configuration). The open configuration of the lips 902 may make iteasier to insert a catheter and spreader into the resealable deliverychannel 218. FIG. 9B shows the lips 902 in a downward rotatedconfiguration (e.g., in a closed configuration). The closedconfiguration of the lips 902 may help secure a catheter or spreaderinside the resealable delivery channel 218. FIG. 9A and FIG. 9B showlips 902 that are inwardly slanted in a manner similar to the embodimentlips 802 a and 802 b shown in FIG. 8. In alternate embodiments, lips maybe differently shaped and oriented, such as horizontally oriented, orupwardly slanted such as lips as 702 illustrated in FIG. 7, or may beconfigured according to other orientations, shapes and configurations,while functioning to retain and seal or otherwise contain a catheter,spreader, tube portion, or other catheter-related component.

In alternate embodiments, rather than rotating about a hinge, theflexible lips may move on different types of joints or movementmechanisms. For example, the flexible lips may move up and down or sideto side within a mounting mechanism or securing mechanism.

The various embodiments also include improved spreader configurations,including different shaped tips (e.g., a curved tip, flanged tip, bulbtip, etc.) configured to work in conjunction with the resealabledelivery channel 218.

FIG. 10 illustrates an embodiment spreader 1000 that includes a mainportion 1002, which may be rigid and coupled to a modular plate or sledmember, and a tip portion 1004 extending from the main spreader portion1002. In the illustrated embodiment, the catheter or tube portion 116may pass through the spreader main portion 1002 and tip portion 1004 andinto the resealable delivery channel 218.

The spreader tip portion 1004 may fit into the resealable deliverychannel, such as by passing between the flexible lips of the resealabledelivery channel 218, as described above. The tip portion 1004 may becurved (as illustrated) or angled to redirect the catheter from thelongitudinal axis of the sled member or modular plate to thelongitudinal axis of the resealable delivery channel 218.

In an embodiment, the spreader 1000 may have a rotatable tip. Forexample, the main portion 1004 of the spreader 100, such as the portionthat may separate the lips of the resealable delivery channel 218, andthe tip portion 1006 from which the catheter or tube portion 116emerges, may be free to rotate with respect to the spreader attachmentportion 1002. In this way, the spreader attachment portion 1002 mayrotate with the sled member and/or modular plate as the catheter isrotated into position, while the tip portion 1006 may stay aligned withthe resealable delivery channel 218. Allowing the main portion 1004 andthe tip portion 1006 to rotate independently, enables the main portion1004 and the tip portion 1006, which may feature a curve or bend 1008 tobe rotated into various positions that may not be otherwise possible. Inother words, the main portion 1004 and the tip portion 1006 may beconnected by a curved portion 1008 such that a longitudinal axis of themain portion 1004 and the tip portion 1006 may be oriented at an angleto one another. The angled orientation enables the main portion 1004 andthe tip portion to be independently rotated, and based on the curvedportion 1008, to be presented at a favorable angle for parting theflexible lips of the resealable delivery channel 218 regardless of thepositioning of the sled member. For example, when the sled member moves,the main portion 1004 may move slightly while the tip portion 1006 mayremain aligned with the delivery channel 218 due to the bend 1008,thereby guiding the catheter or tube portion 116 straight into thechannel 218. Any form of rotating joint may be used between the spreaderattachment portion 1002 and main portion 1004 and the tip portion 1006,including an overlapping sleeve (as illustrated), a slip joint, and abearing sleeve that permit rotation about a longitudinal axis of thespreader assembly. While a curved portion 1008 is illustrated, a curvedjoint may also be used that joins the main portion 1004 and the tipportion 1006 such that the main portion may move while the curved jointallows the tip portion 1006 to maintain an alignment along thelongitudinal axis of the delivery channel 218, such as to provide astraight path for the catheter 116.

In an embodiment, the spreader main portion 1004 may be flexible, suchas more or less flexible than the flexible lips. However, in order toprevent the lips from pinching through the spreader main portion 1004 orthe tip portion 1006 and restricting the movement of a catheter or thetube portion 116, the flexibility of the spreader main portion 1004and/or the tip portion 1006 may be less than the lips. In someembodiments, the spreader may be stiffer than the catheter. Alternately,the spreader main portion 1004 and/or the tip portion 1006 may be rigidwith minimal flexibility.

In further embodiments, the spreader main portion 1004 and/or the tipportion 1006 may be fashioned with various shapes configured to help thespreader and catheter to enter the resealable delivery channel 118and/or remain in the channel during operation while enabling thespreader to spread the flexible lips of the delivery channel as thecatheter is advanced or retracted along the sled base. One problemaddressed by the above described embodiments is that a spreader mayrequire a diameter that is small enough at the point where the spreaderengages the flexible lips of the delivery channel to avoid excessivebending the lips as the spreader is advanced along the sled base.Excessive pressure on the spreader may lead to pinching of a catheter,catheter sheath, tube portion or other catheter related component.However, a small diameter at the tip reduces a force of the lips againstthe spreader thus reduces the forces keeping the spreader within thedelivery channel Conventional spreaders with a consistent diameter alongtheir length, including portions that project into the delivery channel,may be prone to disadvantages in that such spreaders may inadvertently“pop out” of the delivery channel during operation. Thus, furtherembodiments may include shapes that reduce the potential for the tip ofthe spreader to pop out of the delivery channel while presenting anacceptable diameter along the length to avoid over stressing theflexible lips.

FIG. 11 illustrates an embodiment in which the end of a spreader tipportion 1104 may include flanges 1102, such as on opposite sides of thetip portion 1104 that may come into contact with the delivery channel218. The flanges 1102 may be configured to hold the spreader within thedelivery channel 218. The flanges 1102 may be configured with portions1103 that are tapered towards the distal end 1105 of the tip portion1104. The tapered portions 1103 may ease insertion of the tip portion1104 into the resealable delivery channel Tapered flanges 1102 may helpseparate the flexible lips as the spreader is inserted.

In further embodiments, the resealable delivery channel 218 may beconfigured with an internal shape 1203 that is shaped to guide thespreader tip portion 1104, such as when the spreader tip portion 1104 isconfigured with flanges 1102. For example, FIG. 12A illustrates anembodiment in which the end of a spreader tip portion 1104 may beconfigured with a profile that is compatible with that of the internalshape 1203 of the resealable delivery channel 1202. In other words, thespreader tip portion 1104 configured with flanges 1102 may be configuredwith a profile that fits into the internal opening or internal shape1203 of the delivery channel 1202. The shaped resealable deliverychannel 1202 may include flexible lips 1204. At least an inner portionof the lips 1204 may have a shape that conforms with or is compatiblewith the shape of the spreader tip portion 1104. The shaped resealabledelivery channel 1202 may constrain the movement of the spreader tip1104 and the flanges 1102 to a substantially straight path along thedelivery channel 1202 as the catheter is advanced, retracted, and/orrotated.

FIG. 12B illustrates an embodiment in which the resealable deliverychannel 1202 may include a hinge 1203 enabling the resealable deliverychannel 1202 to open. The hinge 1203 may run the entire length of thechannel portion of the resealable delivery channel 1202 dividing theresealable delivery channel 1202 into two portions each including itsown flexible lip 1204 and rotationally coupled together by the hinge1203. The resealable delivery channel 1202 may be opened by rotating thetwo portions away from each other around the hinge 1203. When in an openposition, the flexible lips 1204 may be farther apart from each otherthan when positioned in a closed position. The space between theflexible lips 1204 may more easily accommodate the spreader tip portion1104 with the flanges 1102. The spreader tip portion 1104 with theflanges 1102 may be placed in the resealable delivery channel 1202, andthe two portions of the resealable delivery channel 1202 may be rotatedtoward each other around the hinge 1203 to contain the spreader tipportion 1104 and the flanges 1102. The closed delivery channel 1202 mayconstrain the movement of the spreader tip 1104 and the flanges 1102 toa straight path along the delivery channel 1202 as the catheter isadvanced, retracted, and/or rotated. In embodiments, the hinge 1203 maybe any form of hinge, including a thinned section that is flexible dueto its reduced thickness, a flexible material joining the two portionsof the delivery channel 1202 that enables bending, and a mechanicalhinge that may be any type of known hinge, including a barrel hinge,pivot hinge, butt & mortise hinge, a case hinge, a piano hinge, a flathinge, an H hinge and an HL hinge.

FIG. 13 illustrates another embodiment spreader tip portion 1104including a spherical or bulb-shaped tip 1302. In the illustratedembodiment, the spreader tip portion 1104 with the bulb tip 1302 may beeasier to push in or pull out through the flexible lips of theresealable delivery channel The bulb shaped bulb tip 1302 provides alarger radius than the spreader tip portion 1104. When inside thedelivery channel, the bulb tip 1302 may interact with the flexible lipsto prevent the spreader 1104 from inadvertently popping out of theresealable delivery channel

FIG. 14 illustrates a profile of a resealable delivery channel 218 witha bulb tip spreader 1302 positioned beneath the flexible lips 802. Asillustrated, the flexible lips 802 will present greater resistance towithdrawal of the bulb tip 1302 of the tip than the thinner diameter ofthe spreader tip 1104. Further, when the lips 802 are configured in adownward facing orientation, a natural resistance to upward movement ofthe bulb tip 1302 will be presented. In other words, as an upward forceis exerted on the bulb tip 1302, and correspondingly on the innersurfaces of the lips 802, the lips 802 will press more forcefully on thesides of the spreader tip 1104. A progressively increasing upward forceon the bulb tip 1302 may provide progressively increasing resistance toremoval of the bulb tip 1302 from the delivery channel 218. In thismanner, when the portion of the spreader 1104 that passes through theflexible lips 802 of the delivery channel 218, such as the bulb tip1302, has a diameter just a little larger than a gap between theflexible lips, the bulb tip 1302 may be held in place within the channel218 by the flexible lips 802.

FIG. 15 illustrates a top view of an embodiment resealable deliverychannel 1503 inserted in a sled base 1502. In an embodiment, theflexible lips 1504 of the resealable delivery channel 1503 may beconfigured to include cutouts or other modifications formed in theflexible lips 1504 that result in one or more entry holes 1505 to enabletip of the spreader to easily slide into the track of the resealabledelivery channel 1503, such as in the area of the entry hole 1505. Thetip of the spreader, such as the bulb tip 1302, may be easily insertedin the entry hole 1505 while being constrained by the lips 1504 withinthe other portions of the delivery channel 1503. The one or more entryholes 1505 may be located in a portion of the resealable deliverychannel 1503 that the spreader may not cross during normal operation,such as at a proximal end of the sled base 1502 located away from apatient.

As discussed, the flexible plastic lips 1504 may include features, suchas semi-circular cutouts, that form the one or more entry holes 1505 toenable the spreader to easily slide into the resealable delivery channelin the area of the entry holes 1505. Once inserted, part or all of thespreader may move with the catheter during positioning, such as rotatingwith the catheter. The resealable delivery channel 1503 may additionallybe hinged to open the resealable delivery channel to receive thespreader and to close the resealable delivery channel around thecatheter as described herein above.

Those skilled in the art will recognize that the methods and systems ofthe present invention have many applications, may be implemented in manymanners and, as such, is not to be limited by the preceding exemplaryembodiments and examples. Additionally, the functionality of thecomponents of the preceding embodiments may be implemented in differentmanners. Further, it is to be understood that the steps in theembodiments may be performed in any suitable order, combined into fewersteps or divided into more steps. Thus, the scope of the presentinvention covers conventionally known and future developed variationsand modifications to the system components described herein, as would beunderstood by those skilled in the art.

What is claimed is:
 1. A resealable delivery channel configured to becoupled to a sled base of a catheter positioning system and to guide acatheter along a length of the sled base, the resealable deliverychannel comprising: a channel portion comprising a delivery groove intowhich the catheter is capable of being inserted; and flexible lipscoupled to the channel portion and extending toward one another andparallel to the channel portion along opposed sides of the channelportion, wherein the flexible lips are configured to form at least apartial seal around the catheter and a spreader through which thecatheter is threaded.
 2. The resealable delivery channel of claim 1,wherein an outer side of the flexible lips are configured to slanttoward a bottom of the channel portion.
 3. The resealable deliverychannel of claim 1, wherein the flexible lips are attached to thechannel portion by a rotatable joint.
 4. The resealable delivery channelof claim 3, wherein the rotatable joint comprises a hinge.
 5. Theresealable delivery channel of claim 1, wherein the channel portionincludes a hinge configured to enable the resealable delivery channel tobe opened to receive the spreader.
 6. The resealable delivery channel ofclaim 1, wherein the flexible lips are configured to form an entry holeto enable the spreader to be inserted into the channel portion.
 7. Theresealable delivery channel of claim 1, wherein the at least the partialseal is movable with the one of the catheter and the spreader along thelength of the sled base of the catheter positioning system.
 8. Theresealable delivery channel of claim 1, wherein the flexible lips areconfigured to form a full seal around the one of: the catheter; and thespreader, wherein the full seal is movable with the one of the catheterand the spreader along the length of the sled base of the catheterpositioning system.